NCT05803421

A Study of Daily Oral Orforglipron (LY3502970) Compared With Insulin Glargine in Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,749 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to determine safety and efficacy of orforglipron compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study will last approximately 2 years may include up to 27 visits.

Conditions

• Type 2 Diabetes
• Obesity
• Overweight or Obesity
• Overweight
• Cardiovascular Diseases
• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Orforglipron	Administered orally once daily
DRUG	Insulin Glargine	Administered SC once daily

Timeline

• Start date: 2023-04-03
• Primary completion: 2026-03-16
• Completion: 2026-03-16
• First posted: 2023-04-07
• Last updated: 2026-04-17

Locations

358 sites across 16 countries: United States, Argentina, Austria, Brazil, Czechia, Germany, Greece, India, Italy, Mexico, Puerto Rico, Romania, Slovakia, South Korea, Spain, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study